Cleared Traditional

K922729 - SPARTA WET DRESSING, SODIUM CHLORIDE

K922729 · Sparta Surgical Corp. · General & Plastic Surgery device
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Nov 1992
Decision
171d
Days
-
Risk

K922729 is an FDA 510(k) clearance for the SPARTA WET DRESSING, SODIUM CHLORIDE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sparta Surgical Corp. (Hammonton, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 171 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K922729

510(k) Number K922729 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 05, 1992
Decision Date November 23, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 663
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K922729.
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
MEDTRAX PACKING STRIP
K926207 · Medtrax Industries, Inc. · May 1993
INMAN MEDICAL OIL EMULSION DRESSING
K921290 · Inman Medical Corp. · Nov 1992
INMAN MEDICAL PETROLATUM DRESSING
K921289 · Inman Medical Corp. · Nov 1992
PROLONGED OCCLUSION DRESSING II
K920874 · Ferndal Laboratories · Jun 1992
PROLONGED OCCLUSION DRESSING I
K920875 · Ferndal Laboratories · Jun 1992
K922729 · SPARTA WET DRESSING, SODIUM CHLORIDE
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